Quality Improvement, Research, and the Institutional Review Board

2007 ◽  
Vol 29 (3) ◽  
pp. 4-9 ◽  
Author(s):  
Linda Harrington
2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Darpan I. Patel ◽  
Kathleen R. Stevens ◽  
Frank Puga

The purpose of this paper is to report the variance in institutional review board (IRB) reviews as part of the implementation of a multisite, quality improvement study through the Improvement Science Research Network (ISRN) and recommend strategies successful in procuring timely IRB approval. Using correspondence documents as data sources, the level of review was identified and time to submission, time to approval, and time to study start were analyzed. Thirteen of the 14 IRBs conducted independent reviews of the project. Twelve IRBs approved the study through expedited review while two IRBs reviewed the project at a full board meeting. Lastly, 11 of the 14 sites required documented consent. The greatest delay in approval was seen early on in the IRB process with site PIs averaging 45.1 ± 31.8 days to submit the study to the IRB. IRB approvals were relatively quick with an average of 14 ± 5.7 days to approval. The delay in study submission may be attributed to a lack of clear definitions and differing interpretations of the regulations that challenge researchers.


2016 ◽  
Vol 7 (4) ◽  
pp. 265-274 ◽  
Author(s):  
Daniel E. Hall ◽  
Ulrike Feske ◽  
Barbara H. Hanusa ◽  
Bruce S. Ling ◽  
Roslyn A. Stone ◽  
...  

2012 ◽  
Vol 4 (1) ◽  
pp. 106-108 ◽  
Author(s):  
Lisa N. Conforti ◽  
Brian J. Hess ◽  
Kathryn M. Ross ◽  
Lorna A. Lynn ◽  
Eric S. Holmboe

Abstract Introduction Quality improvement (QI) activities are an important part of residency training. National studies are needed to inform best practices in QI training and experience for residents. The impact of the Institutional Review Board (IRB) process on such studies is not well described. Methods This observational study looked at time, length, comfort level, and overall quality of experience for 42 residency training programs in obtaining approval or exemption for a nationally based educational QI study. Results For the 42 programs in the study, the time period to IRB approval/exemption was highly variable, ranging from less than 1 week to 56.5 weeks; mean and median time was approximately 18 weeks (SD, 10.8). Greater reported comfort with the IRB process was associated with less time to obtain approval (r  =  −.50; P < .01; 95% CI, −0.70 to −0.23). A more positive overall quality of experience with the IRB process was also associated with less time to obtain IRB approval (r  =  −.60; P < .01; 95% CI, −0.74 to −0.36). Discussion The IRB process for residency programs initiating QI studies shows considerable variance that is not explained by attributes of the projects. New strategies are needed to assist and expedite IRB processes for QI research in educational settings and reduce interinstitutional variability and increase comfort level among educators with the IRB process.


Author(s):  
Min-Fu Tsan

Performance measurement leads to quality improvement, because performance measurement can identify areas of vulnerability to guide quality improvement activities. Recommendations from empirical institutional review board (IRB) performance measurement data on research approval criteria, expedited review protocols, exempt protocols, and IRB continuing review requirements published over the past 10 years are reviewed here to improve the quality and efficiency of IRBs. Implementation of these recommendations should result in improvements that can be evaluated by follow-up performance measurements.


2002 ◽  
Vol 113 (7) ◽  
pp. 575-579 ◽  
Author(s):  
Peter K Lindenauer ◽  
Evan M Benjamin ◽  
Deborah Naglieri-Prescod ◽  
Janice Fitzgerald ◽  
Penelope Pekow

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